In a phase 3 clinical trial, a monthly injection of Xolair
significantly reduced hives and itchiness in these patients,
according to a study published online in the
The New England Journal of Medicine.

"This is the magic bullet that patients have been waiting for for the last 40 years," said study lead author Dr. Marcus Maurer, a professor of dermatology and allergy at Charit-Universitatsmedizin in Berlin, The New York Timesreported.

Maurer has received consulting fees from several drug companies,
including Genentech and Novartis, which paid for the study.

The study results are encouraging, according to Dr. Jonathan
Bernstein, a professor of medicine and an allergy specialist at the
University of Cincinnati, who was not involved in the study.

"The drug is not a cure, but it will advance our ability to manage these patients," he told The Times.

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Doctor Performs Bloodless Lung Transplants

Bloodless lung transplants being performed by an American doctor
hint at a possible new way of performing surgery in the future.

Dr. Scott Scheinin, of The Methodist Hospital in Houston, said a
growing body of research led him to believe that blood transfusions
often pose unnecessary risks and should be avoided when possible,
even in complicated cases,
The New York Timesreported.

By choosing patients with low odds of complications, he felt he
could operate almost as safely without blood transfusions as with
it. Some patients refuse blood transfusions due to religious
beliefs or for other reasons.

The first so-called bloodless lung transplant was conducted in
1996 at Johns Hopkins Hospital. So far, 11 so-called bloodless lung
transplants have been attempted at Methodist over three years,
The Timesreported.

Hospital officials were initially reluctant to approve this type
of procedure.

"My job is to push risk away, so I wasn't really excited about it. But the numbers were very convincing," Dr. A. Osama Gaber, the hospital's director of transplantation, told The Times.

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Anemia Drug Recalled Due to Reactions Among Dialysis
Patients

A voluntary recall has been issued by the makers of the anemia
drug Omontys because of reports that the treatment can cause
serious, and sometimes fatal, allergic reactions in some kidney
dialysis patients.

Takeda Pharmaceuticals Co., of Osaka, Japan, and Palo Alto,
Calif.-based Affymax Inc. said in a joint statement on their
websites Sunday that all lots of the drug have been recalled and
doctors should stop prescribing Omontys (peginesatide). The
medication is used to treat anemia in people with chronic kidney
disease.

Among the first 25,000 patients who received a first injection
of Omontys, .02 percent suffered fatal allergic reactions that
included anaphylaxis shock, the companies said in the statement.
The reaction typically occurred within 30 minutes of the first
injection of Omontys.

In a statement released Sunday, the FDA said it has received 19
reports of anaphylaxis, three resulting in death, from dialysis
centers in the United States.

Some of the patients were resuscitated by doctors, the agency
added.

"Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys," said Howard Sklamberg, director, Office of Compliance, FDA's Center for Drug Evaluation and Research. "Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more."

Overall, about .2 percent of dialysis patients suffered some
level of allergic reaction, and a third of those were serious
enough to require medical intervention and sometimes
hospitalization, the companies said in their joint statement.

"Our company is working with the FDA and Affymax, and decided to voluntarily recall Omontys to put patients' safety first," said Kazumi Kobayashi, a spokesman for Takeda, Bloomberg Newsreported.

The U.S. Food and Drug Administration approved the treatment
last March, according to
Bloomberg.

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New Breast Cancer Drug Approved by FDA

A new drug for late-stage breast cancer has been approved by the
U.S. Food and Drug Administration.

Genentech's Kadcyla (ado-trastuzumab emtansine) is for use in
patients with HER2-positive, late-stage breast cancer who were
previously treated with another anti-HER2 drug called Herceptin
(trastuzmab) and a class of chemotherapy drugs called taxanes,
which are commonly used to treat breast cancer.

"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein," he explained.

The FDA's approval of the drug was based on a study of 991
patients. Kadcyla carries a boxed warning that it can cause liver
and heart problems and even death. It can also cause
life-threatening birth defects, the agency said.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.